UH3 Project: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)
Overview
Principal Investigators:
Sponsoring Institution: Kaiser Foundation Research Institute
Collaborators:
- Kaiser Permanente Department of Research, Oakland, CA (Performance Site)
- Sutter Health Research Institute, Palo Alto, CA (Performance Site)
- Institute of Family Health, New York City, NY (Performance Site)
- RAND Corporation, Santa Monica, CA
NIH Institute Providing Oversight: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT04982315
Trial Status: Completed
Trial Summary
Study question and significance: Acupuncture is a safe, effective treatment for chronic low back pain in adults, and the American College of Physicians recommends the treatment as first-line therapy. However, few studies, and no large-scale randomized trials, have examined the safety and efficacy of acupuncture in older adults specifically.
Design and setting: Cluster randomized trial comparing standard and enhanced courses of acupuncture with usual care alone in adults aged 65 years and older with chronic low back pain. The study included 800 patients in 4 healthcare systems in the United States from August 2021 to October 2022.
Intervention and methods: Participants were randomly assigned to 1 of 3 groups: (1) a standard 12-week course of acupuncture plus usual medical care; (2) standard acupuncture enhanced with 4 to 6 maintenance sessions plus usual care; or (3) usual care alone.
Findings: At 6 months and 12 months after treatment, patients in both the standard and enhanced acupuncture groups experienced significantly greater reductions in pain and pain-related disability than patients in the usual care group. The improvements did not differ significantly between the standard and enhanced courses of acupuncture.
Conclusions and relevance: Older patients with chronic low back pain who receive acupuncture treatment have greater improvements in pain and disability compared with patients who receive usual care alone. Acupuncture is a safe, effective treatment option for older adults with chronic low back pain.
Data and Resource Sharing
- BackInAction-2021-UH3 Follow-up
BackInAction-Ethics and Regulatory UH3 Follow-up
- AcuOA UG3 Minutes and Supplement_C
AcuOA (BackInAction) Ethics and Regulatory Discussion
Featured Interviews
Drs. DeBar and Sherman discuss the BackInAction (formerly AcuOA) NIH Collaboratory Trial.
News and Interviews
- News_Enhanced Acupuncture Strategy Found to Be Cost-Saving in Older Adults With Chronic Low Back Pain
January 12, 2026: Enhanced Acupuncture Strategy Found to Be Cost-Saving in Older Adults With Chronic Low Back Pain
- News_A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
- News_In BackInAction Pragmatic Trial, Acupuncture Improved Back Pain–Related Disability in Older Adults
September 15, 2025: In BackInAction Pragmatic Trial, Acupuncture Improved Back Pain–Related Disability in Older Adults
- News_NIH Collaboratory Researchers Consider Posttrial Responsibilities
August 25, 2025: NIH Collaboratory Researchers Consider Posttrial Responsibilities
- News_BackInAction Finds Higher Baseline Clinical and Social Risks Among FQHC Participants
September 9, 2025: BackInAction Finds Higher Baseline Clinical and Social Risks Among FQHC Participants
- News_As Their Studies Wrap Up, Researchers Share Lessons for Pragmatic Trials
July 1, 2025: As Their Studies Wrap Up, Researchers Share Lessons for Pragmatic Trials
- News_Results of BackInAction Pragmatic Trial of Acupuncture in Low Back Pain, in This Week’s PCT Grand Rounds
May 7, 2025: Results of BackInAction Pragmatic Trial of Acupuncture in Low Back Pain, in This Week’s PCT Grand Rounds
- News_A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
- News_Seasoned Collaboratory PIs Give Tips to New PRISM Pragmatic Trials
November 19, 2020: Seasoned Collaboratory PIs Give Tips to New PRISM Pragmatic Trials
- News_NIH Collaboratory Researchers Highlight Ethical Obligation, Value of Sharing Trial Results With Participants
Written Interview: NIH Collaboratory Researchers Highlight Ethical Obligation, Value of Sharing Trial Results With Participants
Products and Publications
- Herman et al Spine (Phila Pa 1976) 2026
Cost-effectiveness of acupuncture needling for older adults with chronic low back pain
- DeBar LL et al JAMA Netw Open 2025
BackInAction Main Outcome Paper
- Teets et al Glob Adv Integr Med Health 2025
Recruitment and retention for an acupuncture trial in an underrepresented 65 and older population with chronic low back pain
- Justice et al Contemp Clin Trials 2025
Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults
- Wang et al Integr Med Res 2024
Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials
- Zigler et al Contemp Clin Trials 2023
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- DeBar et al Contemp Clin Trials 2023
BackInAction Study Design Paper
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Nielsen et al Glob Adv Health Med 2021
Acupuncture intervention protocol: consensus process for a pragmatic randomized controlled trial of acupuncture for management of chronic low back pain in older adults: an NIH Heal Initiative funded project
- BackInAction Study Snapshot
BackInAction Study Snapshot
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which Pragmatic Trials Should Have a DSMB?
- Living Textbook_How Are PRO Measures Used
Living Textbook: How are PRO Measures Used?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
Presentations
- 00_Marsolo_combined_FINAL 2
Demystifying Data Sharing
- 03_Goertz_Sunsetting Trials _Final_NO Panel slides
Perspectives From Sunsetting NIH Collaboratory Trials on Next Steps for ePCTs
- SC-Mtg-2024-Day2-Goertz
Building and Sustaining Reusable Infrastructure for ePCTs
- SC-Mtg-2024-Day2-DeBar
BackInAction
- HEAL US Pain Foundation CA presentation DeBar 13Sep2023_final
Evaluating Acupuncture for Older Adults with Chronic Low Back Pain in a Pragmatic Fashion: the Back In Action study
- IFH Response&Success_Symposium poster 24May2023
IFH: Response and Success As Partner in Multi-Site NIH Acupuncture Research Study
- DCTR_SCT_overall_final Walter_21May2023
Improving Racial and Ethnic Diversity in Clinical Trials
- SAR_BIAPresentation_2023_Eng_18May2023_final
Lessons Learned from the BackInAction Pragmatic Trial of Acupuncture Among Older Adults: Unique Challenges and Opportunities at a New York City FQHC
- Consortium_InnovationIntegrationfinal Teets 28Feb2023
Innovation & Integration in Acupuncture Research in the Underserved: Embedding Research in an FQHC
- Poster_HCSRN_Feb2023_BIA_v8_F1 Sanchez 21Feb2023
“Who Says Older Folks Aren’t Tech-Savvy? Experience with a Fully Electronic Consent Procedure in a Trial with Older Adults”
- Poster_HCSRN_Feb2023_BIA_v8_F1
Who Says Older Folks Aren’t Tech-Savvy? Experience with a Fully Electronic Consent Procedure in a Trial with Older Adults
- 2023 HCSRN Poster_BackInAction_Final
Recruiting for a multisite pragmatic clinical trial during COVID-19
- SC-Mtg-2023-Day2-DeBar-Back in Action
Lynn DeBar Back in Action Presentation 2023 Steering Committee Meeting
- International Congress on INtegrative Medicine and Health_Nielsen poster
Collecting Treatment Data Efficiently in Large Trials of Acupuncture: STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) meets Technology
- International Forum on Back and Neck Pain Research in Primary Care_Sherman
Pragmatic trial of acupuncture for chronic low back pain (cLBP) in older adults
- AcuOA_Sherman_DeBar_PRISM Kickoff_FINAL1
BackInAction (formerly AcuOA) Presentation at the PRISM Kickoff Meetings